Sr. QA GCP Manager

San Jose  ‐ Onsite
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Keywords

Description

I am currently in charge of finding the new Sr. Manager of GCP for a mid-sized pharmaceutical company in the San Jose area. This company currently has over 20 on-going clinical trials and will be going commercial with their oncology drug by 2014. I have spoke directly with the hiring manager and I know that the most important thing for a candidate to posses is passion because they are racing against time to save lives. The best candidates should also posses the follwing experience.
  • Minimum of 8 to 10+ years' experience in the pharmaceutical/biotechnology industry
  • Minimum of 7+ years' auditing in one of the following areas: GCP, GLP, GPvP
  • Expert knowledge of technical concepts required for all aspects of GCP Auditing, to include all types of GCP audits; e.g., Study Sites, Vendors, essential study documentation
  • Solid understanding of domestic and international pharmaceutical/Biotechnology auditing standards
  • Extensive experience supporting regulatory authority inspections of clinical research activities
  • Hands-on experience managing quality and compliance projects and programs
  • Proven ability in driving quality process improvement initiatives.
  • Extensive leadership experience and mentoring skills Thorough knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH Guidelines


To find out more about Real please visit www.realstaffing.com
Start date
10/2013
From
Real Staffing
Published at
09.10.2013
Project ID:
609994
Contract type
Permanent
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